OncoMatch

OncoMatch/Clinical Trials/NCT07795528

Postoperative Circulating Tumor DNA Monitoring in Stage I-III Driver-Mutant Colon Adenocarcinoma

Is NCT07795528 recruiting? Yes, currently enrolling (Sep 2026).

RecruitingRuijin HospitalNCT07795528Data as of Sep 2026Location: China

This multicenter prospective observational cohort study will enroll 392 patients with stage I-III colon adenocarcinoma who undergo curative resection and whose tumors harbor at least one prespecified oncogenic driver mutation (KRAS, NRAS, BRAF, or PIK3CA). Serial plasma circulating tumor DNA (ctDNA) testing for molecular residual disease (MRD) will be performed with a standardized 10-gene next-generation sequencing (NGS) panel at predefined time points during 3 years of postoperative follow-up. The primary objective is to evaluate the association between postoperative ctDNA-based MRD status and recurrence-free survival (RFS). Secondary objectives include evaluating overall survival (OS), the interval between first MRD detection and radiologically confirmed recurrence, and the association between longitudinal MRD changes and outcomes following adjuvant chemotherapy.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: BRAF driver mutation

Required: KRAS driver mutation

Required: NRAS driver mutation

Required: PIK3CA driver mutation

Disease stage

Required: Stage I, II, III

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

no prior anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy) before surgery

Cannot have received: radiation therapy

no prior anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy) before surgery

Cannot have received: targeted therapy

no prior anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy) before surgery

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07795528 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require BRAF?

Yes, BRAF driver mutation is a required biomarker for enrollment.

Does this trial require KRAS?

Yes, KRAS driver mutation is a required biomarker for enrollment.

Does this trial require NRAS?

Yes, NRAS driver mutation is a required biomarker for enrollment.

What disease stage is eligible?

Stage I or II or III is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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